A Pilot Study of Neoadjuvant Chemotherapy Combined With Bevacizumab for Locally Advanced Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
Background: Neoadjuvant chemoradiotherapy (CRT) and total mesorectum excision (TME) has become the standard therapy for the treatment of locally advanced rectal cancer (LARC) to reduce the local recurrence rate, however, no improvement of distant metastasis rate was observed, and the incidence of postoperative local recurrence and distant metastasis can reach more than 25%. It is still a challenge for us to improve the RO resection rate of locally advanced rectal cancer and reduce the incidence of local recurrence and distant metastasis.
详细描述
Objective
compared with the postoperative adjuvant therapy, neoadjuvant chemotherapy has shown better compliance of LARC patients, and may be more effective in reducing the incidence of local recurrence and distant metastasis. This study used the anti-angiogenesis drugs beacizumab and chemotherapy in patients with LARC for neoadjuvant chemotherapy, and investigated the short-term efficacy to provide objective basis for the selection of neoadjuvant therapy.
Methods: 70 patients with rectal adenocarcinoma clinical staging in Stage II or Stage III were included for neoadjuvant therapy followed by TME, of which 35 underwent neoadjuvant radiotherapy, and other 35 underwent neoadjuvant chemotherapy+beacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical stage II or stage III rectal cancer patients diagnosed by preoperative biopsy pathology report, endoscopic examination report and preoperative abdominal pelvic dynamic contrast enhanced-MRI examination (DCE-MRI);
- •Primary tumor lesions within 4~12 cm from the anus through endoscopic examination;
- •No distant metastasis and intestinal obstruction;
- •No surgical contraindications;
- •Can be treated with neoadjuvant chemotherapy confirmed by normal routine examination;
- •informed consent with patients and family members before treatment.
排除标准
- •history of beacizumab allergy, being treated with other therapy important viscera dysfunction and severe heart disease, including congestive heart failure, arrhythmia beyond the control, long-term drug treatment of angina pectoris, heart valve disease, myocardial infarction, and resistant hypertension; infectious wound and uncontrollable history of mental illness; infectious sexual diseases.
研究组 & 干预措施
Experimental group
beacizumab+ neoadjuvant chemotherapy (FOLFIRI+beacizumab)
干预措施: FOLFIRI+beacizumab (Procedure)
Control group
neoadjuvant CRT for consecutive 5 weeks
干预措施: CRT (Procedure)
结局指标
主要结局
R0 resection rate
时间窗: 3 years
percent
次要结局
- disease-free survival (DFS)(3 years)
- overall survival (OS)(3 years)
- overall response rate (ORR)(3 years)
研究者
DuNan
Principal Investigator
Chinese PLA General Hospital